Paranasal sinuses are cavities formed within the bones of the face that are accessible via an individual's nasal cavity. The paranasal sinuses include the frontal sinuses, the sphenoid sinuses, the ethmoid sinuses, and the maxillary sinuses. Sino-nasal anatomy includes bilateral inferior, middle and supreme turbinate and the midline nasal septum. The paranasal sinuses and nose are lined with mucous-producing respiratory epithelial tissue.
Normally, mucous produced by the linings of the sino-nasal sinuses slowly drains out of each sinus through an opening known as an ostium. Some conditions, however, can interfere with the drainage of the mucous. A healthy sino-nasal condition depends upon proper mucous drainage from the sinus cavities and the nose. When this natural process is disrupted by the effects of allergen, other bioactive particulate matter deposits or abnormal anatomic variations a condition of mucous stasis in the sinus cavities or the nose. As a consequence, nasal lining mucositis and/or sino-nasal disorders (e.g., a sinus infection, sinus headache, epistaxis, nasal obstruction, rhinorrhea) can result. Some of the conventional systemic approaches to treating these disorders often result in cutaneous rash, diarrhea, bacterial resistance from antibiotic use, adrenal suppression, weight gain from steroid medications, hypertension, sleep disturbance from decongestant use, epistaxis, headache, vertigo and others.
Surgery that is performed on the paranasal sinus cavities results in altered, modified or otherwise widened sinus drainage pathways compared to native outflow tracts.
Direct application of a substance to a sinus through a nasal cavity may avoid some of the side-effects listed above that are inherent in a systemic approach to treating sinusitis, rhinitis and/or mucositis.
However, due to the lateral or superior location of sinus outflow tracts the introduction of a substance via a trans-nasal route may result in a large majority of the substance bypassing the intended sinus cavity ostia.
More specifically, the post-surgical maxillary sinus ostia is located on the lateral nasal wall approximately 3.0 to 4.0 centimeters from the apex of the external nasal vestibule and approximately at a 45 degree angle with respect to the floor of the nose. Thus, a substance delivered using a device introduced into the nose at approximately 45 degrees from the floor of the nose with an approximate length of 3 to 4 centimeters and with the capability of directing a substance at an 80 to 90 degree angle relative to the device itself would have the capability of directly delivering a substance to the maxillary sinus cavity when properly oriented.
Additionally, the post-surgical frontal sinus outflow tract is located superiorly in the nasal cavity at approximately 5 to 6 centimeters from the apex of the external nasal vestibule at approximately 75° to 85° relative to the floor of the nose. Thus, a substance delivered using a device introduced into the nose at approximately 45 degrees from the floor of the nose with an approximate length of 3 to 4 centimeters and with the capability of directing a substance at an 80 to 90 degree angle relative to the device itself would have the capability of directly delivering a substance to the frontal sinus cavity when properly oriented.
Accordingly, there is a need for a device, system, and method of treatment that has the capability to quickly and accurately apply a substance directly to a laterally or superiorly located paranasal sinus outflow tract. The present disclosure discusses a device that satisfies such needs, among the others delineated.
Direct application of a substance to an infected sinus through a nasal cavity will avoid some of the side-effects listed above that are inherent in a systemic approach. However, the introduction of a substance via a trans-nasal route may result in a large majority of the substance flowing down the individual's throat, resulting in possible aspiration, coughing and or choking; if the substance enters the oral cavity it also is distasteful, which further exacerbates the unpleasantness. Additionally, if a substance is forcibly introduced into a nasal cavity it is possible to overcome physiologic proximal Eustachian tube resistance resulting in the substance contaminating the middle-ear. The presence of a substance (other than physiologic body-temperature aeration) in the middle-ear may result in aural fullness, otitis effusion, otitis media, hearing loss (possibly permanent), ossicular chain injury, damage to the middle-ear mucosal lining, dizziness/unsteadiness, nystagmus, nausea and others.
Accordingly, there is a need for a device and/or system that has the capability to quickly and accurately apply a substance to a paranasal sinus and/or sino-nasal cavity, prevent the substance applied to a paranasal sinus and/or sino-nasal cavity from flowing down a patient's throat and/or prevent the substance from contaminating the middle-ear cavity. The present disclosure discusses a device that satisfies such needs, among the others delineated.
Agents used in medicated sinus lavage are commonly supplied in capsule or other form; many individuals with dexterity problems are unable to manage the delivery of medication supplied in capsule or other form into sinus irrigation solution.
With respect to solubility of agents administered as a sinus lavage, there exist a category of agents that are immiscible in an aqueous or saline environment therefore presenting a challenge to delivery of a consistent agent concentration.
The use of saline or other sino-nasal irrigation solution delivered in a non-linear, turbulent, or pulsatile manner provides potentially additional cleansing properties over a solution delivered as a constant, uniform stream.
The effective use of gravity-assist sino-nasal lavage can be limited by an inability to control the flow of irrigation solution due to the siphon effect, i.e. a tube used to convey liquid upwards from a reservoir and then flows down to a lower level due to gravity, once the liquid has been forced into the tube and elevated, flow continues unaided and cannot easily be controlled or stopped.
The effective use of gravity-assist sino-nasal lavage can be further limited by an inability to extend the neck and look upwards, as is required in the application of conventional sino-nasal irrigation systems that rely on gravity to dispense the solution. This limitation is particularly acute for persons with neck extension limitations or persons who experience dizziness in this position, in particular elderly persons.
Sino-nasal rinsing can be limited by design features that are selective for specific anatomy, specifically that of adult versus children.